← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K103282 # LAPAROSCOPIC DISSECTOR (K103282) _Applied Medical Resources Corp. · GEI · Nov 16, 2010 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K103282 ## Device Facts - **Applicant:** Applied Medical Resources Corp. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Nov 16, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic, 3rd-Party Reviewed ## Intended Use The Applied Medical Laparoscopic Dissector is indicated for use during minimally invasive procedures for grasping, mobilizing, dissecting and cauterizing tissue. ## Device Story The Laparoscopic Dissector is a sterile, single-use, disposable surgical instrument for minimally invasive procedures. It features a slender shaft with an ergonomic handle and articulated jaws at the tip. The device is inserted through a trocar; the shaft rotates 360° for optimal tissue approach. A toggle on the handle operates the jaws to grasp, mobilize, or dissect tissue. For cauterization, the device connects to a standard electrosurgical generator via an accessory cord to deliver monopolar energy to the jaws. Used by surgeons in clinical settings, the device facilitates tissue manipulation and hemostasis, potentially reducing surgical trauma and improving procedural efficiency. ## Clinical Evidence Bench testing only. Testing included dimensional comparison, dielectric withstand (generator and mains frequency), monopolar functionality, tissue holding/dissecting/piercing/opening, jaw clamping force, thermal safety, mechanical abuse, and environmental conditioning. ## Technological Characteristics Materials: polymers and stainless steel. Design: slender shaft, ergonomic handle, articulated jaws. Energy: monopolar electrosurgical energy via external generator. Dimensions: straight and angled shafts, two lengths. Sterilization: gamma irradiation (SAL 10^-6). Connectivity: accessory cord to electrosurgical generator. ## Regulatory Identification An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. ## Predicate Devices - ENDOPATH Endoscopic Instruments ([K984240](/device/K984240.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains a sequence of handwritten alphanumeric characters. The characters are 'K', '1', '0', '3', '2', '8', and '2'. The characters are written in a clear and legible manner. Image /page/0/Picture/1 description: The image shows the logo for Applied Medical. The logo consists of the word "Applied" in large, bold font, with the word "Medical" underneath in a smaller font. To the right of the text is a triangular graphic with curved lines inside. ## 510(k) SUMMARY Page 1 of 2 SUBMITTED BY: Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA, 92688 (949) 713-8000 CONTACT PERSON: Frans VandenBroek Principal Specialist, Regulatory Affairs (949) 713-8369 (949) 713-8205 (FAX) NOV 1 6 2010 DATE OF PREPARATION: August 27, 2010 TRADE NAME: Laparoscopic Dissector COMMON NAME: Tissue dissector CLASSIFICATION NAME: Electrosurgical cutting and coagulating device and accessories, class II, CFR 878.4400, product code GEI PREDICATE DEVICE: K984240, ENDOPATH Endoscopic Instruments DEVICE DESCRIPTION: The Applied Medical Laparoscopic Dissector is a sterile, single use, disposable surgical instrument designed for minimally invasive surgical procedures. It fits through a trocar and is used to grasp, mobilize and dissect tissue. The dissector may be connected to a standard electrosurgical generator for performing monopolar cautery. The dissector is substantially equivalent to the predicate device in size, function, performance and indications for use. INTENDED USE: The Applied Medical Laparoscopic Dissector is indicated for use during minimally invasive procedures for grasping, mobilizing, dissecting and cauterizing tissue. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The dissector shares a common design with Applied Medical's laparoscopic graspers and scissors. All are made of various polymers and stainless steel, and all feature a slender shaft with a handle at one end and articulated jaws (or scissor blades) at the tip. The shaft may be rotated 360° for optimum approach to tissue that is to be dissected. The handle is constructed in line with the shaft and is ergonomically shaped to fit the hand of the user. A toggle on the handle closes and opens the jaws. The curved articulated jaws are similar to the jaws of the predicate device. ﺎ ﻟﻤﻠ {1}------------------------------------------------ K103282 As is the case with the predicate device, the jaws of Applied's dissector may be energized by a standard electrosurgical generator. An accessory cord connects the dissector to the generator which delivers monopolar energy to the jaws for cauterizing tissue. The Applied laparoscopic dissectors will be manufactured with straight and angled shafts and in two different lengths. Packaging consists of a Tyvek/Mylar peel pouch and a carton. Sterilization is via gamma irradiation; sterility assurance level will be 10-6. DISCUSSION OF NONCLINICAL TESTS SUBMITTED: Applied Medical created a dedicated test method designed to confirm safety and efficacy of the dissector as well as substantial equivalence relative to the predicate device of K984240. These tests focused on: - 0 Dimensional comparison to predicate device - Dielectric withstand (generator frequency) and establishment of voltage rating with the 0 active electrode/insulated shaft - Dielectric withstand (generator frequency) of device handle . - o Dielectric withstand (mains frequency) - o Monopolar functionality - o Tissue holding, dissecting, piercing and opening - � Jaw clamping force test - . Thermal safety なく - . Mechanical abuse - . Environmental conditioning CONCLUSIONS DRAWN FROM TESTING: Applied's performance and functional testing demonstrated that the Applied laparoscopic tissue dissector is substantially ecouitr to the predicate device of K984240 and introduces no new safety and effectivenery iquival. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three parallel lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Applied Medical Resources Corporation % Underwriters Laboratories, Inc. Mr. Casey Conry 1285 Walt Whitman Road Melville, New York 11747 NUV 16 2010 Re: K103282 Trade/Device Name: Laparoscopic Dissector Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 04, 2010 Received: November 05, 2010 Dear Mr. Conry: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you; however, that device labeling must be truthful and not micleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your devine can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act {3}------------------------------------------------ Page 2 - Mr. Casey Conry or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. cerely yours, For Dm. Dender Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDICATIONS FOR USE NOV 1 6 2010 510(k) Number (if known): Not yet assigned k103282 Device Name: Laparoscopic Dissector Indications for Use: The Laparoscopic Dissector is indicated for use during minimally invasive procedures for grasping, mobilizing, dissecting and cauterizing tissue. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R.S. Jordan for mxm (Division Sign-(Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K103282 Attachment I - 1 Page 1 of --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K103282](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K103282) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com